HealthyNCT03485313
Beta-hCG Test Reference Range Determination
An observational study of Healthy, run by Response Biomedical Corp. at 1 site in Canada.
Trial summary
Prospective, single-centre study to determine the reference range (95th percentile) of human chorionic gonadotropin (hCG) levels in a healthy, non-pregnant, adult female population using the RAMP® Total β-hCG test. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 137 participants
- Where
- 1 siteCanada
- Study dates
- 25 Apr 2018to 29 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately two hundred-fifty (250) healthy, non-pregnant adult female subjects will be enrolled in the study. Because hCG levels in blood increase with age, the study population will be divided into two age groups: 18 to 40 years and >40 years, with approximately 125 subjects per group.There are no enrollment restrictions based upon race or ethnic origin.
Who may be able to join
- Apparently healthy, non-pregnant females, of any race.
- >18 years of age.
- Willing to voluntarily agree to sign a consent form.
Who cannot join
- Current pregnancy, suspected pregnancy, or pregnancy within previous 12 months.
- Currently lactating/nursing a child.
- Current diagnosis of Gestational Trophoblastic Disease, Gestational Trophoblastic Tumor or Gestational Trophoblastic Neoplasia.
- Current diagnosis of non-trophoblastic tumors.
- Current diagnosis of cancer and/or has undergone immunotherapy in the previous 12 months.
- Current diagnosis of a serious health condition that involves inpatient care or continuing treatment by a health care provider, such as:
Show all 12Show fewer
- Conditions or treatments that result in continuous or episodic incapacity (e.g. pneumonia, epilepsy).
- Permanent or long-term conditions (e.g. HIV, Alzheimer's, severe stroke).
- Conditions requiring multiple treatment/recovery cycles (e.g. kidney disease).
- Hospitalization (for >24 hours) or major surgery within previous 3 months.
- Unable, or unwilling, to provide required blood sample for testing.
- Investigator believes subject is unsuitable for inclusion in the trial (i.e. has serious condition(s) or other reason(s) that could limit their ability to participate in the study; or impact the scientific integrity of the study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation to Determine the Expected Values Distribution of β-hCG for the RAMP® Total β-hCG Test in a Healthy, Non-pregnant Reference Population
Prospective, single-centre study to determine the reference range (95th percentile) of human chorionic gonadotropin (hCG) levels in a healthy, non-pregnant, adult female population using the RAMP® Total β-hCG test.
Read the detailed description
Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the placenta shortly after implantation of a fertilized ovum into the uterine wall and the rapid rise of blood hCG concentration after conception makes it an excellent marker for confirmation and monitoring of early pregnancy. As such, levels in the blood of non-pregnant premenopausal individuals are low, typically < 5 mIU/mL (milli-International Unit per milliliter).
In terms of identifying a clinically significant range of expected hCG values as determined by the RAMP β-hCG test, a 95th percentile of a healthy, non-pregnant, adult female reference population [upper reference limit (URL)] shall be determined in this study.
Subjects who meet the inclusion and exclusion criteria, and give informed consent will be enrolled in this study. Because hCG levels in blood increase with age, the study population will be divided into two age groups: 18 to 40 years and >40 years, with approximately 125 subjects per group.
One EDTA (ethylenediaminetetraacetic acid) blood sample will be collected from each subject via standard venipuncture. The maximum trial duration for each subject will be one visit/blood draw.
- Conditions
- Healthy
- Keywords
- Healthy, Volunteer, Female, Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of blood hCG level.
Measurement of hCG in a single EDTA blood sample from healthy, non-pregnant adult female subjects using the RAMP Total β-hCG test.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start25 Apr 2018
- Primary completion18 Jul 2018
- Study completion29 Aug 2018
Why it stopped: Study stopped due to slow enrollment; sufficient data collected for analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Response Biomedical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485313
- Sponsor's protocol ID
- CSP027
- Status last verified
- Jan 2019
- First submitted
- 26 Mar 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation to Determine the Expected Values Distribution of β-hCG for the RAMP® Total β-hCG Test in a Healthy, Non-pregnant Reference Population
- ClinicalTrials.gov ID
- NCT03485313
- Acronym / sponsor ID
- CSP027
- Conditions
- Healthy
- Keywords
- Healthy, Volunteer, Female, Pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study stopped due to slow enrollment; sufficient data collected for analysis.
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Response Biomedical Corp.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, single-centre study to determine the reference range (95th percentile) of human chorionic gonadotropin (hCG) levels in a healthy, non-pregnant, adult female population using the RAMP® Total β-hCG test.
Detailed description
Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the placenta shortly after implantation of a fertilized ovum into the uterine wall and the rapid rise of blood hCG concentration after conception makes it an excellent marker for confirmation and monitoring of early pregnancy. As such, levels in the blood of non-pregnant premenopausal individuals are low, typically < 5 mIU/mL (milli-International Unit per milliliter).
In terms of identifying a clinically significant range of expected hCG values as determined by the RAMP β-hCG test, a 95th percentile of a healthy, non-pregnant, adult female reference population [upper reference limit (URL)] shall be determined in this study.
Subjects who meet the inclusion and exclusion criteria, and give informed consent will be enrolled in this study. Because hCG levels in blood increase with age, the study population will be divided into two age groups: 18 to 40 years and >40 years, with approximately 125 subjects per group.
One EDTA (ethylenediaminetetraacetic acid) blood sample will be collected from each subject via standard venipuncture. The maximum trial duration for each subject will be one visit/blood draw.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately two hundred-fifty (250) healthy, non-pregnant adult female subjects will be enrolled in the study. Because hCG levels in blood increase with age, the study population will be divided into two age groups: 18 to 40 years and >40 years, with approximately 125 subjects per group.There are no enrollment restrictions based upon race or ethnic origin.
Key inclusion criteria (3 listed)
- Apparently healthy, non-pregnant females, of any race.
- >18 years of age.
- Willing to voluntarily agree to sign a consent form.
Key exclusion criteria (12 listed)
- Current pregnancy, suspected pregnancy, or pregnancy within previous 12 months.
- Currently lactating/nursing a child.
- Current diagnosis of Gestational Trophoblastic Disease, Gestational Trophoblastic Tumor or Gestational Trophoblastic Neoplasia.
- Current diagnosis of non-trophoblastic tumors.
- Current diagnosis of cancer and/or has undergone immunotherapy in the previous 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of blood hCG level.
Time frame: baseline
Measurement of hCG in a single EDTA blood sample from healthy, non-pregnant adult female subjects using the RAMP Total β-hCG test.
Results and safety
The study was stopped early (reason given: Study stopped due to slow enrollment; sufficient data collected for analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Response Biomedical Corp. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study stopped due to slow enrollment; sufficient data collected for analysis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of blood hCG level. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.